A multicenter experience with generic tacrolimus conversion.

Abstract:

BACKGROUND:The first generic tacrolimus product gained Food and Drug Administration approval in August 2009. This prospective, observational trial sought to determine the need for dose titrations and measure drug cost savings on conversion to generic tacrolimus. METHODS:Transplant recipients on stable tacrolimus doses were converted from brand to generic tacrolimus on a mg:mg basis. Data were collected at the time of generic conversion (study arm) and at a time point exactly 6 months before conversion (control arm) for all subjects. RESULTS:Seventy conversions from four centers are reported. Subjects were a mean of 70 months after kidney (n=37), liver (n=28), or multiorgan (n=5) transplant. In the study arm, mean tacrolimus doses were 4.4 and 4.5 mg/d and mean tacrolimus trough concentrations were 5.8 and 5.9 ng/mL before and after conversion, respectively. In the control arm, mean tacrolimus doses were 4.6 and 4.6 mg/d and mean tacrolimus trough concentrations were 6.1 and 5.9 ng/mL before and after the control time point, respectively. Dose titrations occurred in five patients (7%) in the control arm and 15 patients (21%) in the study arm (P=0.028). Mean monthly drug costs were $645 for brand, $593 for generic, and $595 for generic after dose titrations. Mean monthly patient copays were $38 for brand and $15 for generic. CONCLUSIONS:These cumulative data show that dose requirements and trough levels are similar between brand and generic tacrolimus and that generic substitution allows for savings. However, postconversion monitoring is prudent as patients may require dose titration.

journal_name

Transplantation

journal_title

Transplantation

authors

McDevitt-Potter LM,Sadaka B,Tichy EM,Rogers CC,Gabardi S

doi

10.1097/TP.0b013e31822a79ad

subject

Has Abstract

pub_date

2011-09-27 00:00:00

pages

653-7

issue

6

eissn

0041-1337

issn

1534-6080

journal_volume

92

pub_type

临床试验,杂志文章,多中心研究
  • Immunohistologic analysis of human renal allograft dysfunction.

    abstract::The value of percutaneous core needle biopsy in the immunohistological evaluation of renal allograft dysfunction was studied in 72 consecutive biopsies performed in 42 patients. The phenotypes of infiltrating cells mediating graft destruction were identified with monoclonal antibodies and immunoperoxidase staining tec...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198701000-00022

    authors: Waltzer WC,Miller F,Arnold A,Anaise D,Rapaport FT

    更新日期:1987-01-01 00:00:00

  • Ultrasound changes within the liver after total pancreatectomy and intrahepatic islet cell autotransplantation.

    abstract:OBJECTIVE:Intrahepatic infusion is the most common method of islet autotransplantation. Structural and functional changes within the liver may result from a number of factors, including embolization of the terminal branches of the portal vein, the effects of high insulin concentration on surrounding hepatocytes or resp...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e31817348d6

    authors: Ong SL,Pollard C,Rees Y,Garcea G,Webb M,Illouz S,Berry DP,Dennison AR

    更新日期:2008-06-27 00:00:00

  • Kidney transplantation from anti-HBc+ donors: results from a retrospective Italian study.

    abstract:BACKGROUND:The risk of transmitting a hepatitis B virus (HBV) infection from donor kidneys with a past HBV serological profile may be negligible. Data on HBV transmission to kidney transplant recipients from donor organs that were anti-HBc/HBsAg in Italy has not been previously reported. Anti-HBc testing in cadaver org...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.tp.0000189930.89031.1b

    authors: De Feo TM,Grossi P,Poli F,Mozzi F,Messa P,Minetti E,Sandrini S,Boschiero L,Rigotti P,Maresca C,Rolla D,Chiaramonte S,Gotti E,Caldara R,Briano G,Scalamogna M

    更新日期:2006-01-15 00:00:00

  • Transient complement inhibition plus T-cell immunosuppression induces long-term survival of mouse-to-rat cardiac xenografts.

    abstract:BACKGROUND:The use of anti-B-cell and T-cell immunosuppressive agents leads to only a few weeks' survival of mouse-to-rat cardiac xenografts. METHODS:BALB/c cardiac xenografts were transplanted to Lewis rats treated with cyclosporine (CsA) and/or cobra venom factor (CVF). RESULTS:CsA alone did not prolong xenograft s...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199805150-00012

    authors: Koyamada N,Miyatake T,Candinas D,Mark W,Hechenleitner P,Hancock WW,Soares MP,Bach FH

    更新日期:1998-05-15 00:00:00

  • Acute renal injury in the interferon-gamma gene knockout mouse: effect on cytokine gene expression.

    abstract::We studied major histocompatibility complex (MHC) and cytokine mRNA induction after renal injury in the absence of interferon-gamma (IFN-gamma) using IFN-gamma gene knockout (GKO) mice. The left renal pedicle of normal (wild-type) and GKO BALB/c mice was clamped for 60 minutes; cytokine and MHC mRNA expression were mo...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199560120-00031

    authors: Goes N,Urmson J,Vincent D,Halloran PF

    更新日期:1995-12-27 00:00:00

  • Graft-protective role of high pretransplantation IgA-anti-Fab autoantibodies: confirmatory evidence obtained in more than 4000 kidney transplants. The Collaborative Transplant Study.

    abstract:BACKGROUND:Preliminary studies showed an excellent success rate of kidney grafts in patients with high pretransplantation serum levels of IgA autoantibodies directed against the Fab region of the human IgG molecule. METHODS:With the collaboration of 30 centers from around the world, we attempted to verify the role of ...

    journal_title:Transplantation

    pub_type: 评论,杂志文章,多中心研究

    doi:10.1097/00007890-200004150-00021

    authors: Süsal C,Döhler B,Opelz G

    更新日期:2000-04-15 00:00:00

  • Targeted endothelial delivery of nanosized catalase immunoconjugates protects lung grafts donated after cardiac death.

    abstract:BACKGROUND:Donor organ shortage represents a major problem in lung transplantation. Donation after cardiac death could help to expand the pool of organs, but the additional period of warm ischemia after cardiac arrest aggravates primary graft dysfunction. The pulmonary endothelium of the graft constitutes an important ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e318226bc6b

    authors: Preissler G,Loehe F,Huff IV,Ebersberger U,Shuvaev VV,Bittmann I,Hermanns I,Kirkpatrick JC,Fischer K,Eichhorn ME,Winter H,Jauch KW,Albelda SM,Muzykantov VR,Wiewrodt R

    更新日期:2011-08-27 00:00:00

  • Effect of FK506 treatment on allocytolytic T lymphocyte induction in vivo: differential effects of FK506 on L3T4+ and Ly2+ T cells.

    abstract::Although FK506 has been widely investigated as a potent suppressor of organ allograft rejection in animals, little is known about the effect of FK506 on T cell responses to allografts in vivo. In the present study, we have studied the effect of FK506 on the induction of allocytolytic T lymphocyte using mice primed wit...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199008000-00021

    authors: Maruyama M,Suzuki H,Yamashita N,Yano S

    更新日期:1990-08-01 00:00:00

  • Immunity to Vaccine-preventable Viral Infections in Australians Being Evaluated for Liver Transplantation.

    abstract:BACKGROUND:Vaccine-preventable viral infections are associated with increased risk of morbidity and mortality in immunocompromised patients. Current guidelines recommend routine screening and vaccination of all patients before solid organ transplantation. We studied rates of immunity against vaccine-preventable viruses...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0000000000002722

    authors: Gardiner A,Liu K,Bonnichsen M,Joshi V,Davis RJ,Strasser SI

    更新日期:2019-11-01 00:00:00

  • Characterisation of collagen VI within the islet-exocrine interface of the human pancreas: implications for clinical islet isolation?

    abstract:BACKGROUND:To optimize the methods used for human islet isolation for transplantation, it is important to improve our understanding of the structure of the islet-exocrine interface. In this study, the composition of collagen subtypes in the interface have been characterized and quantified in human pancreas. METHODS:Hu...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/01.tp.0000197482.91227.df

    authors: Hughes SJ,Clark A,McShane P,Contractor HH,Gray DW,Johnson PR

    更新日期:2006-02-15 00:00:00

  • The importance of static lung inflation during organ storage: the impact of varying ischemic intervals in a double lung rat transplantation model.

    abstract::To determine the importance of static lung inflation during storage, graft performance was evaluated at different levels of intratracheal pressure and varying ischemic intervals. Lewis rat lungs were perfused with low-potassium Euro-Collins and stored for 4 or 8 hr either in atelectasis (4 hr: group I; 8 hr: group IV,...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199612270-00004

    authors: Hausen B,Ramsamooj R,Hewitt CW,Schroder F,Beuke M,Poets CF,Schafers HJ

    更新日期:1996-12-27 00:00:00

  • Effect of pretransplant erythropoietin therapy on renal allograft outcome.

    abstract::Erythropoietin (EPO) is widely used among patients with end-stage renal disease awaiting transplantation. Data suggest that EPO therapy may be immunomodulatory. The purpose of this study was to assess the effects of pretransplant EPO therapy on renal allograft outcome. We evaluated 120 consecutive renal transplant rec...

    journal_title:Transplantation

    pub_type: 临床试验,杂志文章

    doi:10.1097/00007890-199610150-00024

    authors: Vasquez EM,Pollak R

    更新日期:1996-10-15 00:00:00

  • Development and Validation of a Multiplex, Bead-based Assay to Detect Antibodies Directed Against SARS-CoV-2 Proteins.

    abstract:BACKGROUND:Transplant recipients who develop COVID-19 may be at increased risk for morbidity and mortality. Determining the status of antibodies against SARS-CoV-2 in both candidates and recipients will be important to understand the epidemiology and clinical course of COVID-19 in this population. While there are multi...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0000000000003524

    authors: Bray RA,Lee JH,Brescia P,Kumar D,Nong T,Shih R,Woodle ES,Maltzman JS,Gebel HM

    更新日期:2021-01-01 00:00:00

  • Accept or Decline? An Analytics-Based Decision Tool for Kidney Offer Evaluation.

    abstract:BACKGROUND:When a deceased-donor kidney is offered to a waitlisted candidate, the decision to accept or decline the organ relies primarily upon a practitioner's experience and intuition. Such decisions must achieve a delicate balance between estimating the immediate benefit of transplantation and the potential for futu...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0000000000001824

    authors: Bertsimas D,Kung J,Trichakis N,Wojciechowski D,Vagefi PA

    更新日期:2017-12-01 00:00:00

  • Attenuation of cyclosporine-induced hypertension by dietary fatty acids in the borderline hypertensive rat.

    abstract::The effects of dietary (10% calories) safflower (SAF), evening primrose (EPO), and fish oil (F) as sources of linoleic acid (control), gamma-linolenic acid, and long-chain n-3 fatty acids, respectively, on cardiovascular and renal responses to chronic (5 weeks) cyclosporine administration were studied in male borderli...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199203000-00030

    authors: Mills DE,Ward RP,McCutcheon D,Dixon H,Ly H,Scholey J

    更新日期:1992-03-01 00:00:00

  • A possible predictive test for graft-versus-host disease in bone marrow graft recipients: the mixed-epidermal cell-lymphocyte reaction.

    abstract::The possible ability of the mixed-epidermal-cell-lymphocyte reaction (MECLR) to detect alloreactivities in HLA-identical MLR negative siblings has been investigated before grafting in 30 donor-recipients pairs and their families. Results indicate that recipients' epidermal cells (EC) can induce proliferative responses...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198603000-00007

    authors: Bagot M,Cordonnier C,Tilkin AF,Heslan M,Vernant JP,Dubertret L,Levy JP

    更新日期:1986-03-01 00:00:00

  • Transplantation of pediatric en bloc cadaver kidneys into adult recipients.

    abstract:BACKGROUND:To maximize the renal donor pool, cadaveric pediatric en bloc kidneys have been transplanted as a dual unit by some transplant centers. We compared the short- and long-term outcomes of adult recipients of cadaveric pediatric en bloc renal transplants versus those of matched recipients of cadaveric adult kidn...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199812270-00020

    authors: Hobart MG,Modlin CS,Kapoor A,Boparai N,Mastroianni B,Papajcik D,Flechner SM,Goldfarb DA,Fischer R,O'Malley KJ,Novick AC

    更新日期:1998-12-27 00:00:00

  • A simplified model for heterotopic rat heart transplantation.

    abstract::A technique for simplified heterotopic rat heart transplantation having only aorto-aortic anastomosis is presented. The heterotopic rt heart survives and functions well when one lung lobe is attached t the transplantation and functions as a reservoir. Iso- and allotransplants are compared by electrocardiogram (ECG) de...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198204000-00020

    authors: Lee S,Macedo AR,Curtis GP,Lee D,Orloff MJ

    更新日期:1982-04-01 00:00:00

  • Clinical and economic impact of flow cytometry crossmatching in primary cadaveric kidney and simultaneous pancreas-kidney transplant recipients.

    abstract::We retrospectively compared the clinical and financial impact of a final cross-match by T cell flow cytometry (FXM) versus conventional complement-dependent cytotoxicity (CXM) in consecutive primary cadaveric kidney (K) and primary simultaneous cadaveric pancreas-kidney (SPK) transplant recipients. Mean follow-up was ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199706150-00018

    authors: Pelletier RP,Orosz CG,Adams PW,Bumgardner GL,Davies EA,Elkhammas EA,Henry ML,Ferguson RM

    更新日期:1997-06-15 00:00:00

  • Tumor necrosis factor, macrophage colony-stimulating factor, and interleukin 1 production within sponge matrix allografts.

    abstract::Neither the presence nor the specific role of secretory cytokines in in vivo allograft rejection has been extensively studied. We quantitated the levels of colony-stimulating factors, tumor necrosis factor, and interleukin 1 within the rejecting allograft. BALB/c (H-2d) mice were implanted with polyurethane sponges co...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199009000-00020

    authors: Ford HR,Hoffman RA,Wing EJ,Magee DM,McIntyre LA,Simmons RL

    更新日期:1990-09-01 00:00:00

  • Modulation of accelerated rejection of cardiac allografts in sensitized rats by anti-interleukin 2 receptor monoclonal antibody and cyclosporine therapy.

    abstract:UNLABELLED:LBNF1 cardiac allografts (Tx) are rejected within 36 hr in LEW rats sensitized with BN skin Tx 7 days earlier, compared to 8-day rejection in unmodified hosts. Treatment with cyclosporine or ART-18, an anti-interleukin 2 receptor (IL-2[R]) mAb monoclonal antibody, abrogates accelerated rejection and prolongs...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199102000-00004

    authors: Kupiec-Weglinski JW,Sablinski T,Hancock WW,Di Stefano R,Mariani G,Mix CT,Tilney NL

    更新日期:1991-02-01 00:00:00

  • Glucocorticoids regulate calcineurin-dependent trans-activating pathways for interleukin-2 gene transcription in human T lymphocytes.

    abstract::Glucocorticoids (GC) inhibit IL-2 gene transcription by interfering with the binding of the nuclear factor activator protein-1 on the IL-2 promoter. Calcineurin, a Ca2+/calmodulin-dependent protein phosphatase, is an essential component of the T cell antigen receptor signal transduction pathway leading to IL-2 gene tr...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:

    authors: Paliogianni F,Boumpas DT

    更新日期:1995-05-15 00:00:00

  • Plant alkaloid tetrandrine and its analog block CD28-costimulated activities of human peripheral blood T cells: potential immunosuppressants in transplantation immunology.

    abstract:BACKGROUND:T lymphocyte activation mediated by CD28 costimulation plays a critical role in graft rejection. Plant alkaloid tetrandrine, purified from a Chinese antirheumatic herb, is a potent immunosuppressant. Here, we examined its effects on several CD28-costimulated T-cell activities. In addition, such effects were ...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199911150-00027

    authors: Lai JH,Ho LJ,Kwan CY,Chang DM,Lee TC

    更新日期:1999-11-15 00:00:00

  • Randomized clinical trial of antithymocyte globulin induction in renal transplantation comparing a fixed daily dose with dose adjustment according to T cell monitoring.

    abstract::Antithymocyte globulin (ATG) has been used successfully for induction therapy as well as for treatment of established allograft rejection. However, this therapy has often been associated with problems of overimmunosuppression and increased costs. In a randomized clinical trial, we compared the immunosuppressive benefi...

    journal_title:Transplantation

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Abouna GM,al-Abdullah IH,Kelly-Sullivan D,Kumar MS,Loose J,Phillips K,Yost S,Seirka D

    更新日期:1995-06-15 00:00:00

  • Induction of donor-specific T-cell hyporesponsiveness using dexamethasone-treated dendritic cells in two fully mismatched rat kidney transplantation models.

    abstract:BACKGROUND:Dendritic cells (DC) can exert powerful immune stimulatory as well as regulatory functions and are therefore important tools for therapeutic strategies. Dexamethasone (Dex) was previously shown to inhibit DC maturation and to induce regulatory properties both in vitro and in vivo. Here, we investigated the i...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/TP.0b013e31818a6682

    authors: Stax AM,Gelderman KA,Schlagwein N,Essers MC,Kamerling SW,Woltman AM,van Kooten C

    更新日期:2008-11-15 00:00:00

  • Local cellular immunity in the draining lymph nodes of mice after immunization with histocompatibility alloantigens.

    abstract::Mice immunized with allogeneic cells exhibit a local component of cellular immunity that is confined to lymph nodes draining the site of immunization. After immunization of C3H mice by skin grafting or by i.p. or footpad injection of F1 hybrid spleen cells, draining lymph nodes show increased responsiveness toward the...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-198107000-00006

    authors: Snow C,Hilgard HR

    更新日期:1981-07-01 00:00:00

  • Prophylaxis with caspofungin for invasive fungal infections in high-risk liver transplant recipients.

    abstract:OBJECTIVE:The aim of this prospective, multicenter, noncomparative, open-label trial was to evaluate the prophylactic use of caspofungin in adult liver transplant recipients at high risk of developing invasive fungal infections (IFI). METHODS:Patients received caspofungin for at least 21 days. A successful treatment o...

    journal_title:Transplantation

    pub_type: 杂志文章,多中心研究

    doi:10.1097/TP.0b013e3181932e76

    authors: Fortún J,Martín-Dávila P,Montejo M,Muñoz P,Cisneros JM,Ramos A,Aragón C,Blanes M,San Juan R,Gavaldá J,Llinares P,GESITRA Study Group.

    更新日期:2009-02-15 00:00:00

  • Use of the methylxanthine derivative A802715 in transplantation immunology: I. Strong in vitro inhibitory effects on CD28-costimulated T cell activities.

    abstract:BACKGROUND:Recently, methylxanthines such as pentoxifylline (PTX) were shown to be immunosuppressive in vitro. Unfortunately, when used in transplant patients, PTX was poorly active as an immunosuppressant. Here we report that the new methylxanthine derivative A802715 not only is more active than PTX, it also suppresse...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199706270-00019

    authors: Lin Y,Goebels J,Rutgeerts O,Kasran A,Van Gool S,Ceuppens J,Schönharting M,Waer M

    更新日期:1997-06-27 00:00:00

  • Functional abnormalities of sinusoidal endothelial cells in rats with acute liver rejection.

    abstract::The purpose of this study was to determine the changes of hepatic sinusoidal endothelial cell (SEC) function in acute liver rejection with respect to receptor-mediated endocytosis. Orthotopic rat liver transplantation was performed in Lewis rats grafted with DA livers and in Lewis rats grafted with Lewis livers as rej...

    journal_title:Transplantation

    pub_type: 杂志文章

    doi:10.1097/00007890-199401000-00006

    authors: Yokoi Y,Nakamura S,Muro H,Baba S

    更新日期:1994-01-01 00:00:00

  • The Immunology of Posttransplant CMV Infection: Potential Effect of CMV Immunoglobulins on Distinct Components of the Immune Response to CMV.

    abstract::The immune response to cytomegalovirus (CMV) infection is highly complex, including humoral, cellular, innate, and adaptive immune responses. Detection of CMV by the innate immune system triggers production of type I IFNs and inflammatory cytokines which initiate cellular and humoral responses that are critical during...

    journal_title:Transplantation

    pub_type: 杂志文章,评审

    doi:10.1097/TP.0000000000001095

    authors: Carbone J

    更新日期:2016-03-01 00:00:00